Aside from whether or not medical tests should be under the FDA’s purview, what is the subtle distinction between ‘a medical test’ and a ‘a service that provides recommendations based on [genetic] markers for potential issues’? I’m pretty sure that’s exactly what a ‘test’ does, albeit possibly with a better warranty.
I am more open to the notion that cheap 'n cheerful non-FDA-approved first-line stuff has its uses, especially since it can be so very cheap, and I accept denial of the FDA, period, as a potentially cogent position (if not necessarily a good idea, given the glorious history of self-regulation); but I’d be wary of conflating dislike of the FDA or FDA approval with assertions that what 23andme is doing is not within the scope of the FDA’s regulatory role, whether you like it or not.
Dancing around the idea that a ‘service that provides recommendations based on markers for potential issues’ is not a ‘medical test’ and does not ‘diagnose anything’ is really edging up on the sophistry of distinction without difference.
If you think that it’s an illigitimate imposition to claim any authority over testing or diagnostics, or even over any aspect of medicine, you’ve got yourself a point to advance; but the distinction you are trying to draw there is spun of rather thin stuff.
